Transcript KDIGO

Guideline Statements
27 guideline statements
Major content areas:
 Immunosuppression
 Graft monitoring and infections
 Cardiovascular disease risk
 Malignancies
 Other complications
Immunosuppression
1)
2)
3)
4)
5)
6)
7)
Induction
Maintenance: initial
Maintenance: long-term
Strategies to reduce cost
Monitoring medications
Treatment of acute rejection
Chronic allograft nephropathy
Graft Monitoring and
Infections
8) Monitoring kidney function
9) Kidney biopsy
10) Recurrent disease
11) Non-adnherence
12) Vaccination
13) Viral diseases
14) Other infections
Cardiovascular Disease Risk
15) Diabetes mellitus
16) Hypertension, dyslipidemia, tobacco use and
obesity
17) Cardiovascular disease management
Malignancies
18) Cancer of the skin and lip
19) Non-skin malignancies
20) Immunosuppressive medication reduction
Other Complications
21) Bone disease
22) Hematologic complications
23) Hyperuricemia and gout
24) Growth and development
25) Sexual function and fertility
26) Life style
27) Mental health
Initial Maintenance
Immunosuppressive Medications
• Recommendations:
• A combination of immunosuppressive medications
as maintenance therapy including a CNI and an
antiproliferative agent, with or without
corticosteroids. (1B)
• Tacrolimus be the first-line CNI used. (2A)
• Tacrolimus or CsA be started before or at the time
of transplantation, rather than delayed until the
onset of graft function. (2D tacrolimus; 2B CsA)
• Mycophenolate be the first-line antiproliferative
agent. (2B)
CNI, calcineurin inhibitor; CsA, cyclosporine A; mTORi,
mammalian target of rapamycin inhibitor(s).
Initial Maintenance
Immunosuppressive Medications
(Contd..)
• Recommendations:
• In patients who are at low immunological
risk and who receive induction therapy,
corticosteroids could be discontinued
during the first week after
transplantation. (2B)
• If mTORi are used, they should not be
started until graft function is established
and surgical wounds are healed. (1B)
Rationale
• Used in combination and at reduced doses, drugs that have
different mechanisms of action may achieve additive
efficacy with limited toxicity.
• The earlier that therapeutic blood levels of a CNI can be
attained, the more effective the CNI will be in preventing
acute rejection.
• There is no reason to delay the initiation of a CNI, and no
evidence that delaying the CNI prevents or ameliorates
DGF.
• Compared to CsA, tacrolimus reduces the risk of acute
rejection and improves graft survival during the first year
of transplantation.
Rationale
• Low-dose tacrolimus minimizes the risk of new-onset diabetes
after transplantation (NODAT) compared to higher doses of
tacrolimus.
• Compared with placebo and azathioprine, mycophenolate
reduces the risk of acute rejection; there is some evidence
thatmycophenolate improves long-term graft survival compared
with azathioprine.
• Avoiding the use of maintenance corticosteroids beyond the first
week after kidney transplantation reduces adverse effects without
affecting graft survival.
• Mammalian target of rapamycin inhibitors (mTORi) have not
been shown to improve patient outcomes when used either as
replacement for antiproliferative agents or CNIs, or as add-on
therapy, and they have important short- and long-term adverse
effects
Long-Term Maintenance
Immunosuppressive Medications
• Recommendations:
• Using lowest planned doses of maintenance
immunosuppressive medications by 2–
4months after transplantation, if there has
been no acute rejection. (2C)
• CNIs be continued rather than withdrawn.
(2B)
• If prednisone is being used beyond the first
week after transplantation, we suggest
prednisone be continued rather than
withdrawn. (2C)
Rationale
• If low-dose CNI was not implemented at the time of
transplantation, CNI dose reduction >2–4months after
transplantation may reduce toxicity yet prevent acute
rejection.
• RCTs show that CNI withdrawal leads to increased acute
rejection, without altering graft survival.
• RCTs show that steroid withdrawal more than 3 months
after transplantation increases the risk of acute rejection.
• Different immunosuppressive medications have different
toxicity profiles and patients vary in their susceptibility
to adverse effects.
Topic Selection and Prioritization Process
For Clinical Practice
Guidelines and
Conferences
Prioritization of CPG Development*



Consistency with the mission of the
organization.
Feasibility of implementation.
Efficiency and utility of the results.
* Recommendations of the Institute of Medicine
WHO Guidelines for Guidelines
 Stage 1. Maximum potential benefit to individual
or group of patients if resources were unlimited.
 Stage 2. Assess tradeoffs between cost of applying
intervention on a population basis and its health
impact (very limited vs. unlimited resources).
 Stage 3. Provide evidentiary basis and assistance
necessary for local Guideline Development Groups
in adopting and grading the
recommendations for regional
implementation considering available
resources.
KDIGO Criteria for
CPG Topic Selection




Prevalence of clinical problem.
Burden of illness imposed by the problem.
Variability in practice
Potential of guidelines to improve health
outcomes.
International Evidence Review Team
Grading Evidence and
Recommendations for Clinical
Practice Guidelines.
A Position Statement from KDIGO
Kidney Int 70:2058-2065, 2006
KDIGO Clinical Practice Guidelines
 Prevention, Diagnosis, Evaluation and
Treatment of Hepatitis C in Chronic
Kidney Disease
Workgroup co-chairs: Michel Jadoul (Belgium) and David
Roth (USA). Published – April 2008, Kidney Int
 Diagnosis, Evaluation, Prevention and
Treatment of Chronic Kidney Disease
Related Mineral and Bone Disorders
(CKD-MBD)
Workgroup co-chairs: Tilman Drüeke (France) and
Sharon Moe (USA). Anticipated Publication – Fall 2008,
Kidney Int
 Care of the Kidney Transplant Recipient
Workgroup co-chairs: Bertram Kasiske (USA) and Martin
Zeier (Germany). Anticipated Publication – Winter 2008,
Kidney Int
 Acute Kidney Injury,
Workgroup co-chairs: Norbert Lameire (Belgium) and
John Kellum (USA). Anticipated Publication – 2009
Guideline Coordination Initiative
 Joint effort of leaders of five Englishlanguage guideline development groups
 Exploring the feasibility of a collaborative
and integrated international approach to
the development of new guidelines and the
updating of existing guidelines in the field
of kidney disease
Guideline Coordination
 Canadian Society of Nephrology (CSN)
Guidelines
 Caring for Australians with Renal
Impairment (CARI) Guidelines - ANZSN
 United Kingdom Renal Association
Guidelines
 European Best Practice (EBPG) Guidelines –
ERA/EDTA
 Kidney Disease Outcomes Quality Initiative
(KDOQI) Guidelines - NKF
 KDIGO
Guideline Coordination
 Globalize (Share) the Evidence – Localize
the Decision Making
 New CPGs: Global KDIGO Guidelines –
Local Implementation
 Existing CPGs: Coordinated, cooperative
process of updating
Guideline Coordination
What we can do together
 Uniformity in grading the evidence and strength of
recommendations (“Grading the evidence and recommendations for
clinical practice guidelines-A position statement from KDIGO”).
 Reconciliation of currently recommended targets (KDIGO
Website-Compare Guidelines).
 Hepatitis C guidelines as first global guidelines in
nephrology for subsequent adoption by participating
organizations, which could then devote their resources to
implementation. Extend to CKD-MBD and Transplant CPGs,
with opportunity to provide input and participate early in the
review process.
Coordination with WHO
 Liaison member on Guideline
Development Groups (where
applicable).
 Participation in Controversies
Conferences.
 Incorporation of KDIGO CKD Staging
into ICD 10-11.
 Adopt the WHO Guidelines for
Guidelines methodology.
Website Guideline Database
Comparison of guidelines as a tool
for the harmonization of
recommended interventions: The
KDIGO website
Kidney International, 2007
Website Resources
 International Clinical Practice
Guidelines in Nephrology
 Guideline Development Summaries
 Target Ranges Comparisons
 Position Statements
 CKD-Mineral and Bone Disorder
 Classification of CKD
www.KDIGO.org
Website Resources
 Global Nephrology Guideline
Database:
 Guideline Overviews
 Guideline Summaries by Topic
 Guideline Target Comparisons
WWW.KDIGO.ORG
KDIGO Controversies Conferences
 WHAT DO WE KNOW
(Available Evidence)
 WHAT CAN WE DO WITH WHAT WE
KNOW
(Recommendations vs. Guidelines)
 WHAT DO WE NEED TO KNOW
(Gaps in knowledge, Research questions)
Third KDIGO
Controversies Conference
Care of the Kidney Transplant
Recipient
Co-chairs: F. Delmonico, USA
M. Zeier, Germany
Lisbon, Portugal
February 2-4, 2006
Fourth KDIGO
Controversies Conference
CKD as a Global Public Health
Problem: Approaches and Initiatives
Co-Chairs: Andrew Levey, Kai-Uwe Eckardt, Adeera
Levin, Allan Collins, Meguid El-Nahas
Amsterdam, Netherlands
October 12-14, 2006
NKF-KDOQI Definition of CKD
KDIGO Modifications (Amsterdam 2004)
Structural or functional abnormalities of the kidneys for >3
months, as manifested by either:
1. Kidney damage, with or without decreased GFR, as defined
by
 pathologic abnormalities
 markers of kidney damage
 urinary abnormalities (proteinuria)
 blood abnormalities (renal tubular syndromes)
 imaging abnormalities
 kidney transplantation
2. GFR <60 ml/min/1.73 m2, with or without kidney damage
Conceptual Model for CKD
Complications
Normal
Increased
risk
Screening
CKD risk
for CKD
reduction;
risk factors:
Screening for
diabetes
CKD
hypertension
age >60
family history
US ethnic
minorities
Damage
 GFR
Kidney
failure
Diagnosis
Estimate
Replacement
& treatment; progression;
by dialysis
Treat
Treat
& transplant
comorbid complications;
conditions;
Prepare for
Slow
replacement
progression
CKD
death
Sixth KDIGO
Controversies Conference
Coordination of Global Practice
Guidelines for Anemia in CKD
Co-Chairs: Francesco Locatelli &
Allen Nissenson
New York
October 15-16, 2007
Fifth KDIGO
Controversies Conference
Clinical Practice Guidelines:
Methodology and Transparency
Co-Chairs: Robert Alpern, Charles
van Ypersele, Katrin Uhlig, &
Alison MacLeod
New York
October 12-13, 2007
KDIGO Position Statements
 Definition and classification of chronic kidney
disease: a position statement from Kidney
Disease: Improving Global Outcomes (KDIGO)
Levey AS, at al: Kidney Int 2005;67:2089-2100.
 Definition, evaluation, and classification of renal
osteodystrophy: a position statement from
Kidney Disease: Improving Global Outcomes
(KDIGO) Moe S, et al: Kidney Int 2006;69:1945-1953.
 A report of the Lisbon Conference on the care of
the kidney transplant recipient. Abbud-Filho M, et
al: Transplantation 83:S1-22, 2007
 Chronic kidney disease as a global public health
problem: approaches and initiatives - a position
statement from Kidney Disease Improving
Global Outcomes. (KDIGO) Levey AS, et al: Kidney
Int 72:247-259, 2007
Mineral and Bone Initiative
 Educational Resources: Clinical Guide to
Bone and Mineral Metabolism in CKD
 Position Statements: Chronic Kidney
Disease-Mineral and Bone Disorder
 Bone Biopsy/Bone Biomarker Correlation
Study
Clinical Guide to Bone and Mineral
Metabolism in CKD
Second KDIGO
Controversies Conference
Definition, Evaluation, and
Classification of Renal
Osteodystrophy.
A Position Statement from
KDIGO
Kidney Int 69:1945-1953, 2006
SUMMARY
• Our primary goal is to improve patient care. We hope to
accomplish this in the short term by helping clinicians know and
better understand the evidence (or lack of evidence) that
determines current practice.
• By making this guideline broadly applicable, our purpose is to
also encourage and enable the establishment and development
of transplant programs worldwide.
• Finally, by providing comprehensive evidence-based
recommendations, this guideline will also help define areas
where evidence is lacking and research is needed.
• Helping to define a research agenda is an often neglected, but
very important function of clinical practice guideline
development.
Kai-Uwe Eckardt, MD
KDIGO Co-Chair
Bertram L. Kasiske, MD
KDIGO Co-Chair
THANK YOU